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FDA has approved Epidiolex, which contains a purified form of the drug substance cannabidiol (CBD) for the treatment of seizures
associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.
The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for nausea associated with cancer chemotherapy and
for the treatment of anorexia associated with weight loss
in AIDS patients. In addition, the FDA’s expanded access (sometimes
called "compassionate use") statutory and regulatory provisions
are designed to facilitate the availability of investigational products to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy available,
either because the patients have exhausted treatment with or are intolerant of
approved therapies, or when the patients are not eligible for an ongoing
clinical trial. To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. The FDA has an important role
to play in supporting scientific research into the medical uses
of cannabis and its constituents in scientifically valid investigations as part of the agency’s drug
review and approval process. -
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